GEN-MKT-18-7897-A
Feb 7, 2025 | Blogs, Pharma, ZenoTOF 7600 system | 0 comments
Read Time: 2 Minutes
Liquid chromatography-mass spectrometry is commonly used for Met ID but confident soft spot identification is not always possible. Imagine the advantage of unambiguous metabolite identification using liquid chromatography-mass spectrometry (LC-MS) reducing the need for additional safety testing during drug discovery. Quickly and easily generate the information you need using routine assays that are robust and efficient, enabling confident decision-making while also saving time and money. Learn more >
Metabolite identification is a key task during drug discovery to establish safety and efficacy of a drug candidate. LC-MS assays for metabolite identification typically use collision-induced dissociation (CID) to fragment ions for structural elucidation, and soft-spot identification. With challenging metabolites, CID doesn’t produce sufficient fragment ions or help with labile modifications and a clear identification cannot be made. This can lead to the need for additional testing to meet regulatory requirements.
EAD is a fragmentation method available on the ZenoTOF 7600 system that causes ions in an LC-MS/MS experiment to fragment in locations that are different from where they fragment with CID, providing additional information to scientists. For metabolite identification, this could mean confident identification of the metabolite and localization of the site of metabolism, removing the need for additional safety testing.
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As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
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